An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH Safety

Sanofi-Synthelabo Research0 个研究点开始时间: 2006年4月27日最近更新: 2021年9月7日

试验速览

暂无简介。

•Male or female patients aged 18 years and higher
•Serum sodium between 115 mmol/L and 132 mmol/L
•Urinary osmolality > 200 mOsm/kg H2O
•Urinary sodium > 30 mmol/L
•Ability to give written informed consent (the informed consent form should be signed by a legally authorized representative if the patient is unable to sign).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients with acute post operative SIADH
•Presence of dilutional hyponatremia in hypervolemic states (CHF and liver disease with Ascites)
•Presence of sign of hypovolemia
•Administration of other V2 receptor antogonists or demeclocycline or lithium within one month, thiazide diuretics or spironolactone within 15 days and urea or loop diuretics within 2 days prior to study drug administration.
•Presence of untreated hypothyroidisme or adrenal deficiency
•Presence of uncontrolled diabetes with fasting glycemia > or equal to 200 mg/dL (> or equal 11.09 mmol/L)
•Administration of inducers of CYP3A4 (phenobarbital, phenytoin, rifampin, Saint John’s Wort) or potent and specific moderate inhibitors of CYP3A4 within two weeks prior to study drug administration
•Inadequate hematological, renal and hepatic functions
•Positive pregnancy test and absence of medically approved contraceptive methods for female of childbearing potential
•Pregnancy or breast-feading

发起方

Sanofi-Synthelabo Research